Effect of Botox Before Modified Lip Repositioning Repositioning Only in Relapse of the Excessive Gingival Display Within One Year

NCT ID: NCT06148961

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-10-30

Brief Summary

The growing interest of patients in esthetic procedures, as well as the development of less invasive protocols in dentistry, has promoted the development of treatment plans that include stability, harmony, and function in orofacial rehabilitation.

Poor esthetics interfere with an individual's personal, social, and professional relationships and is an individual consideration that varies according to the patient's age, time, region, and culture concerning what is considered beautiful.

Detailed Description

People are increasingly being inspired to get more corrective and cosmetic surgeries as an esthetic smile becomes a more fundamental component of what it means to be beautiful.

There are several variables that affect how appealing and esthetic a smile is Esthetic perception varies according to cultural, societal, environmental, and individual factors like experience and educational level Previous studies have shown that a smile with less gingival display (GD) is viewed as more beautiful, with dental professionals being more critical of gingival presentation than laypeople According to research by several authors, the ideal GD ranges from 1 to 3 mm While many factors influence how pleasant a smile is seen, excessive GD (EGD), sometimes referred to as a gummy smile, is regarded as a key factor in smile analysis and one of the main issues connected to an unsatisfactory dental smile.

To reduce the relapse associated with repositioning surgery and to provide a lasting treatment without the need for reapplication, as in the case of the toxin, a combined treatment using the toxin preoperatively was considered.

Conditions

Excessive Gingival Display

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group

botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region.

the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions.

A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

Group Type: EXPERIMENTAL

botox prior to modified lip repostioning

Intervention Type: PROCEDURE

botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region.

the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions.

A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

control group

A surgical marker was used to outline the boundaries of the surgical incision region.

the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions.

A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

Group Type: ACTIVE_COMPARATOR

botox prior to modified lip repostioning

Intervention Type: PROCEDURE

botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region.

the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions.

A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

Interventions

botox prior to modified lip repostioning

botox injection prior to surgical intervention by 5 to 10 days A surgical marker was used to outline the boundaries of the surgical incision region.

the height of the superior incision was measured as 15 mm within the vestibule. Superior and inferior incisions were made with a scalpel blade number 15 and linked bilaterally by two vertical incisions.

A partial thickness dissection was used to remove the strip of the indicated mucosa, exposing the fascia of the connective tissue beneath. When necessary, all salivary glands and frenal attachments were removed. The surgical site was then properly closed using a periosteal simple interrupted suture was put in place prior to the continuous interlocking sutures. It was placed by commencing the needle 2 mm coronal to Per surgery site, 3 to 4 periosteal sutures were typically The new mucosal boundary to the gingiva was stabilized in its new place using this suture

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients that is not satisfied with his smile having excessive gingival display
• Adult Age ≥ 21 years.
• Systemically and periodontally Healthy patients.
• had gingival exposure greater than 3 mm when smiling
• had a hyperactive upper lip with or without other causes of EGD (lip displacement ≥ 9 mm) before botox & ≥ 3mm after.
• Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria

• • smoking

• pregnancy or lactation
• Systemic diseases; neuromuscular,neurological, or psychological disorders or consumption of controlled medication
• Patients having medical condition or any drugs that could affect healing
• Patients with systemic condition that can't undergo minor oral surgery
• Patient allergic to Botox or multiple allergic conditions
• have history of previous Botox injection
• periodontal disease
• excessive gingival display at rest
• those who declined the informed consent or who did not consent to the risks described.
• Those who have deviate smile

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Cherine Emad Mahmoud Mohamed Hamada

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cherine Emad Mahmoud Mohamed Hamada

Giza, , Egypt

Countries

Egypt

Facility Contacts

Cherine E Hamada, TA

Role: primary

cherine.mahmoud@dentistry.cu.edu.eg

+201223405353

Emad M Hamada, Prof

Role: backup

emhamada@hotmail.com

+201223132936

Other Identifiers

2023-2025

Identifier Type: -

Identifier Source: org_study_id